Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified by Sanofi Aventis Healthcare

Overview

The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, addressing issues related to the quality, safety, and efficacy of such goods. This Act was introduced to ensure that therapeutic goods available in the Australian market meet acceptable standards, thereby protecting public health. The Act is administered by the Therapeutic Goods Administration, an agency within the Department of Health, and its primary policy objective is to safeguard the health of Australians by ensuring that therapeutic goods are of an acceptable quality and do not pose unacceptable risks to health. The consent granted in this instance by the delegate of the Secretary of the Department of Health under this Act allows for a temporary exemption from certain regulatory requirements for specified batches of folic acid products, subject to conditions that ensure the safety and quality of the therapeutic goods supplied. On 22 May 2015, the delegate, pursuant to the Therapeutic Goods Act 1989, provided consent for the supply of specific batches of Nature's Own Folic Acid 500mcg and Cenovus Folic Acid 500mcg, which do not fully conform to the requirements set out in the Therapeutic Goods Order No. 78. This consent was issued to address a temporary shortfall in the folic acid content of these products, ensuring they do not fall below 90.0% or exceed 130.0% of the stated content on the label. This action aims to balance the need for ensuring public health protection with the flexibility required in specific circumstances, such as supply chain issues, while maintaining stringent oversight through the specified conditions of the consent.

Scope and Application

The Therapeutic Goods Act 1989, as applied in this instance by the Therapeutic Goods Administration (TGA), governs the regulation of therapeutic goods in Australia, including their quality, safety, and efficacy. This Act applies to therapeutic goods, which include medicines, medical devices, blood, tissues, and other substances that are used for therapeutic purposes. The Act applies to entities such as manufacturers, importers, and suppliers of these goods, ensuring that they comply with relevant regulations and standards. In this specific case, the Act applies to Sanofi-Aventis Healthcare Pty Ltd, which is authorised to supply certain batches of folic acid tablets that do not conform to the specified standards, under strict conditions and for a limited period. The consent granted under the Act is subject to geographical limitations within Australia and applies only to the specified batches until 15 September 2015. The Act also allows for the extension or restriction of its application through subordinate instruments, such as the Therapeutic Goods Orders, which further detail the specific requirements for different types of therapeutic goods.

Key Provisions

Section 14 of the Therapeutic Goods Act 1989 allows the delegate of the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not conform to specified requirements, if certain conditions are met. In this instance, section 14A specifically addresses the consent given for Nature's Own Folic Acid 500mcg and Cenovis Folic Acid 500mcg, which do not meet the standards set out in section 8 of Therapeutic Goods Order No. 78, particularly regarding the content of folic acid. This consent permits the specified batches of these products to be supplied until 15 September 2015, provided they meet the condition that the folic acid content must be between 90.0% and 130.0% of the stated content. The obligations imposed on Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, as the entity applying for and receiving this consent, include ensuring that the specified batches of Nature's Own Folic Acid 500mcg and Cenovis Folic Acid 500mcg comply with the stipulated conditions. This means the active ingredient, folic acid, must be within the allowable range of 90.0% to 130.0% of the stated content on the product label. Additionally, they must ensure that the consent applies only to the batches listed and that these products are supplied within the designated timeframe, ending 15 September 2015. Failure to comply with the conditions set by the delegate of the Secretary can result in legal consequences. The Therapeutic Goods Act 1989 outlines various offences related to the supply of non-compliant therapeutic goods. If Sanofi-Aventis Healthcare Pty Ltd or any other party involved in the supply of these products fails to adhere to the consent conditions, they could face legal action. The penalties for such breaches can be severe, including fines and potential criminal charges. While the specific maximum penalties are not detailed in the Gazette, they are typically outlined in the Act itself and can include substantial financial penalties for corporate entities, as well as potential imprisonment for individuals found guilty of serious offences.